A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
NCT06929286 · Phase 3 · Baltimore, Maryland, United States
- Condition
- Bladder Cancer
- Disease stage
- Stage I-IV
- Phase
- Phase 3
- Study type
- DRUG
- Intervention
- Nadofaragene Firadenovec, Gemcitabine, Docetaxel
- Age
- 21 Years to
- Gender
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Research institution
- Memorial Sloan Kettering Cancer Center
- Facility
- Johns Hopkins University (Data Collection Only)
- Research center
- Johns Hopkins University (Data Collection Only)
Summary
The purpose of this study is to compare the effectiveness of different FDA-approved/NCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).
Inclusion criteria
* 21 years of age or older * Being treated for high-grade NMIBC (Tis, Ta, or T1) under the care of the participating treating urologists * One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed °Any amount of maintenance BCG is allowed * In the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment * An intravesical agent can include BCG or any other NMIBC treatment * Up to 15 months from the last instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence/suspicion of recurrent disease (by urinary cytology, imaging, or cystoscopy) within 12 months of last exposure to an intravesical agent. * In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to IFNa, severe immunosuppression) and there is uncertainty over whether nadofaragene is better than "best usual care"
Exclusion criteria
* Opting for treatment with radical cystectomy * Currently receiving treatment on a clinical trial of an experimental therapy for NMIBC * Prior exposure to nadofaragene firadenovec
Primary outcomes
high-grade recurrence-free survival
Secondary outcomes
Progression-free survival